Department of Health and Human Services September 30, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Announcement of Requirements and Registration for “Million Hearts Challenge”
The ``Million Hearts Challenge'' is a multidisciplinary call to innovators and developers to create an application that activates and empowers patients to take charge of their cardiovascular disease. Winning entries have the potential to help patients combat the nation's leading cause of death through medication adherence, a healthier diet, and a more active lifestyle while promoting the goals of the Million Hearts campaign. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. No. 111-358).
Announcement of Requirements and Registration for “popHealth Tools Development Challenge”
The ``popHealth Tools Development Challenge'' tasks developers with creating applications that leverage the popHealth open source framework, existing functionality, standards, and sample datasets to improve patient care and provide greater insight into patient populations. Winning entries will extend the capabilities of popHealth, increasing its value to healthcare providers and EHR vendors. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
New Animal Drugs for Use in Animal Feeds; Melengestrol; Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of melengestrol acetate and monensin in two-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans, and Standards Related to Reinsurance, Risk Corridors and Risk Adjustment; Extension of Comment Period
This document extends the comment period for two proposed rules published in the Federal Register on July 15, 2011. One proposed rule would implement the new Affordable Insurance Exchanges (``Exchanges''), consistent with Title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The other proposed rule would implement standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with Title I of the Affordable Care Act. The comment period for both proposed rules, which would have ended on September 28, 2011, is extended to October 31, 2011.
Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' This draft guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.
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